This device is intended to solve a global barrier to commercialisation of cell therapies, by simplifying the delivery of these therapies to patients by addressing significant challenges of delivery at the point-of-care.
Cell-based therapies are generally produced and cryopreserved under Good Manufacturing Practice (GMP) conditions; however, thawing of these cryopreserved GMP products at clinical sites is usually done in standard laboratory water-baths. These are at risk of producing inconsistencies between treatments and can result in poor performance in clinical trials or poor efficacy of treatment, both of which present significant risks to commercial viability of a cell therapy.
Keith Thompson, CEO of the Cell Therapy Catapult said: “The development of this “Thaw in Clinic” technology will fill a crucial gap in the GMP logistical chain that has to be developed to make these advanced therapies routinely available to patients.”
“Delivery of cryogenically preserved CBTs presents unique challenges to both manufacturers and clinicians,” said Stuart Milne, Chief Technology Officer of Asymptote. “Standardisation of product handling prior to patient administration is fundamental to reduce both cost and variability of treatments and to improve patient outcomes. Asymptote is excited to be involved in the creation of a platform delivery system designed to address this healthcare need.”
The concept was developed by the Cell Therapy Catapult during discussions with its customers. As there were a number of opportunities identified, a challenge call was released to identify the best partner. The Cambridge company, Asymptote, was successful and the project will start this month.
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